BridgeMD
New treatment option for Coronary Arterial Disease
Official title ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions
ClinicalTrials.gov ID: NCT07407738
What this study is testing
- What it's testing
- Coronary artery disease is caused by narrowing of the artery lumen. Treatment with Percutaneous Coronary Intervention (PCI) may be needed.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients aged ≥18 years undergoing PCI for stable or unstable angina or staged procedure after successful treatment of a myocardial infarction where...
- Native de novo coronary lesions
- Vessel diameter between 2.5mm - 4.0mm
- Lesion Length: ≤40mm
- Severe Calcification:
You likely can't join if
- Ejection fraction less than 25%
- Lesion located in Left Main (LM) coronary artery
- Calcifications located mostly \> 0.5 mm from the vessel lumen.
- Severe renal Impairment; Serum Creatinine \> 220 μmol or currently undergoing hemodialysis
- Severe lesion tortuosity where OCT is judged impossible to cross.
- Inability to tolerate dual antiplatelet therapy for 6 months or longer
See the full eligibility criteria
- Patients aged ≥18 years undergoing PCI for stable or unstable angina or staged procedure after successful treatment of a myocardial infarction where heart enzymes are decreasing Angiographic criteria:
- Native de novo coronary lesions
- Vessel diameter between 2.5mm - 4.0mm
- Lesion Length: ≤40mm
- Severe Calcification:
- Calcification visible on the upper and the lower sides of the vessel wall in at least two angiographic projections that differ ≥ 60° from each other
- Presence of severe calcified protruding noduli
- No flow disturbances at baseline (Thrombolysis in Myocardial Infarction [TIMI] 3 flow at baseline)
- Target lesion with diameter stenosis ≥70% by visual, or ≥50% with evidence of clinical ischemia OCT Criteria:
- Total calcium arc \> 180° or
- Presence of a protruding calcified noduli
- Ejection fraction less than 25%
- Lesion located in Left Main (LM) coronary artery
- Calcifications located mostly \> 0.5 mm from the vessel lumen.
- Severe renal Impairment; Serum Creatinine \> 220 μmol or currently undergoing hemodialysis
- Severe lesion tortuosity where OCT is judged impossible to cross.
- Inability to tolerate dual antiplatelet therapy for 6 months or longer
- Inability to obtain inform consent or deemed poorly compliant by the investigator
- Presence of permanent pacemaker
- Angiographic evidence of thrombus in the target vessel
- Target lesion located at or involving within 5mm of the coronary ostium of the Left Anterior Descending artery (LAD), Left Circumflex artery (LCX)
- Target lesion is a chronic total occlusion (CTO)
- Presence of aneurysm within 10mm proximal or distal to the target lesion
The study team makes the final eligibility decision.
Where it's taking place
- Lyon, France
- Paris, France
- Valenciennes, France
- Katowice, Poland
- Krakow, Poland
- Lubin, Poland
- Wroclaw, Poland
- Madrid, Spain
- Murcia, Spain
- Seville, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lyon, France; Paris, France; Valenciennes, France; Katowice, Poland; Krakow, Poland; Lubin, Poland and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.